Regulations governing the omega-3 market vary greatly between regions but in common is the fact there is no official, government-recommended dietary intake (RDI) anywhere in the world and approved health claims are few.
The omega-3 industry has been growing rapidly for many years but many think its expansion would have been even greater were it not for the uncertainty created by this situation.
Cardiovascular health claims are only permitted in some countries like the US and the UK and the lack of an RDI is becoming an elephant in the room that is getting bigger by the day. Further discussion and, ultimately, resolution on these matters is required and sooner rather than later.
The Food and Drug Administration (FDA)-approved qualified health claim relates to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and states:
"Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids.”
The UK claim states:
“Eating 3g weekly, or 0.45g daily, long chain omega-3 polyunsaturated fatty acids, as part of a healthy lifestyle, helps maintain heart health.”
The European Union is in the process of assessing 1000s of health claims, some of which relate to omega-3 health benefits in areas ranging from brain function to maternal and infant health.
Resolution on these is due by January, 2010 and it is expected the rejection or approval of omega-3 claims that will apply across the bloc’s 27-member states will resonate internationally and may prompt a raft of approvals.
The RDI situation is a little strange given the volume of scientific study and the existence of unofficial recommendations from creditable groups such as the Institute of Medicine (IoM) in the US and the UK Export Group on Vitamins and Minerals (EVM).
In a 2002 report, IoM recommended a safe level for EPA and DHA of about 270mg per day, a figure industry would consider as being at the low end of the spectrum.
The American Dietetic Association recommend a minimum combined intake of 500 mg/day EPA and DHA to support heart health.
In 2003, an EVM report recommended 450mg. There are higher measures such as 2000mg per day from a Japanese report.
The Global Organization for EPA and DHA (GOED), which represent suppliers and distributors of EPA/DHA fatty acids as well as omega-3 food and supplements manufacturers, is busy commissioning and collating the kind of scientific and other information that may lead to the establishment RDIs in major markets such as Europe, North America and Asia.
GOED argues the opportunity to express the omega-3 content of their foods and supplements as a percentage of a government-backed RDI is a powerful marketing tool as well as being in consumer interest to have access to this kind of information.
“GOED believes the FDA should consider an approach more akin to nutrient content claims on macronutrients like fiber, where chronic disease prevention was a criterion in establishing nutrient content claims rather than just nutrient deficiencies,” GOED wrote in a letter last year.
The lack of an official RDI has led to some products using unofficial recommendations as faux-RDIs which has led to criticism from groups like the Washington DC-based Center for Science in the Public Interest (CSPI).
Market leader Ocean Nutrition Canada said last year that official RDIs were 2-3 years off in North America and Europe.
New European Union hygiene regulations based on HACCP principles are also having an impact which groups such as GOED claim could decimate the industry.
An extension of the Directive’s imposition, due in November, 2007, has been granted until the end of 2008.
In a recent report on the European omega-3 market, Frost & Sullivan predicted the impact of the legislation would be “low-to-medium” due to effective lobbying campaigns.